Surgical compression clips

ABSTRACT

A surgical clip assembly which includes a pair of generally linear compression elements for securing tissue between them and for applying to the secured tissue a compression force. The clip assembly has an initial, open position in which the linear compression elements may be positioned about tissue to be secured between them. The assembly also has a final, closed position where the compression elements are substantially parallel to each other, applying a compressive force to the secured tissue. The clip assembly also includes a force means disposed between the pair of compression elements and operative to transmit operational forces between them.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.60/780,446, filed Mar. 9, 2006.

FIELD OF THE INVENTION

The present invention relates to the field of surgical compression clipsgenerally, and, in particular, to the field of surgical compressionclips, at least partially formed from shape memory material.

BACKGROUND OF THE INVENTION

Several methods are known in the art for joining tissue portions at thesite of organ resections, particularly gastrointestinal (GI) tractresections, or at the site of other types of tissue perforations ortissue openings. These include threads for manual suturing, staplers formechanical suturing, tissue adhesives and compression rings and clips.

While manual suturing is universally known and relatively inexpensive,the degree of success depends considerably on the skill of the surgeon.Another disadvantage of this technique is that post-operativecomplications are common. Further, suturing an organ results in lack ofsmoothness of the tissue therein, which, when the sutured organ is partof the gastrointestinal tract, hampers peristalsis in the sutured area.Finally, suturing is both labor and time consuming.

Increasingly, stapling is being used for suturing. Staplers formechanical suturing ensure a reliable joining of tissue and reduce thetime needed for surgery compared with manual suturing. However, afterhealing, metal staples remain in place along the perimeter of thesuture, which reduces elasticity of the junction and adversely affectsperistalsis when the sutured organ is part of the gastrointestinaltract. These complications often lead to strictures and inflammatoryreactions to the foreign bodies left behind. Staples also often lead toundesired leakage of blood and other body liquids into the region ofresected tissue further resulting in severe infection. Additionally,stapling mechanisms generally are relatively large and fairly rigid,limiting the maneuverability of an endoscope used in conjunction withthe stapling mechanism. This lack of maneuverability restricts anendoscopic approach to many locations within the body.

Junctions using compression devices, such as rings (or loops) and clips,ensure the best seal and post-operative functioning of the organs. Thecompression force exerted by compression rings is applied onlymomentarily at the tissue junction and is reduced as the tissue iscrushed. Clips made of memory alloys enable portions of tissue to bepressed together with increasing pressure as they are heated, due to theinherent properties of the alloys. Their design is cheap and they aresmall in size. Moreover, when used in the GI tract they are oftenself-evacuated.

A major disadvantage of known clips is that they permit compression ofonly approximately 80-85% of the junction perimeter, thus requiringadditional manual sutures, which reduce the integrity of the seal of thejunction during the healing period and its elasticity during thepost-operative period. Furthermore, this additional suturing isproblematic inasmuch as it has to be carried out across a joint whichincludes a portion of the clip, thereby rendering difficult the sealingand anastomosis of the organ portions.

The compressive force exerted by clips generally is not equal at bothends of the clip because of the clips' typically asymmetricconstruction. Similarly, compression does not act along a line betweenthe two compressing portions holding the tissue to be compressed. Thiscan lead to the clip disengaging from the closure site before closure iscomplete and scar tissue mature.

Typically, clips do not necessarily have a securing mechanism againstslipping off the tissue. Clips as currently designed may also affect themaneuverability of an endoscope.

DEFINITIONS

“Proximal” relates to the side of a clip or device closest to the user,while “distal” refers to the side of a clip or device furthest from theuser.

“Lesion” may be used in place of the word “polyp” “perforation”,hemorrhoid; tissue adjacent to a resected site, or openings withintissue generated by any surgical procedures, without any intent atdifferentiating these different types of lesions, except wherespecifically indicated.

“Gastrointestinal tract” or its equivalents are used in thespecifications and claims without intent of being limiting. Other organsystems, and lesions found therein, are also contemplated as beingtreatable with the compression clips and devices described in thepresent specification.

“Hinge spring” is one type of a “force applier” and this latter term maybe used herein interchangeably with hinge spring without any intent atdifferentiating between these terms, except where specificallyindicated. Accordingly, the latch described herein, as well as elementshaving other shapes, may also be considered to be force appliers if theyare used for, and their operation is based on, their being formed fromand possessing the force applying properties of shape memory materials.Hinge springs may be described herein as “hinge members”, “force means”and “hinge members” again without any attempt at differentiating betweenthese terms except where specifically indicated.

“Endoscope” as used herein should be construed as including all types ofinvasive instruments, flexible or rigid, having scope features. Theseinclude, but are not limited to, colonscopes, gastroscopes, laproscopes,and rectoscopes. Similarly, the use of “endoscopic” is to be construedas referring to all types of invasive scopes.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved surgical compressionclip having force appliers/force means formed of a shape memory alloymaterial. These clips may be used for joining tissue at the resectionsite in resections of many kinds, as well as for closing various othertypes of organ perforations. They may be used inter alia inpolypectomies, gastrectomies and gastroplastic procedures.

It is an object of the present invention to provide a surgicalcompression clip which exerts a constant compressive force irrespectiveof thickness of the compressed tissue, and irrespective of the changesit undergoes during the wound healing process. Such a clip reduces thechances of liquid leakage after resection while ensuring proper healingand closure of the resected site. Typically, but without intending to belimiting, no foreign body is left behind after tissue closure iscomplete.

It is a further object of the present invention to provide a clip thatensures protection against the clip being expelled before tissue closureis complete.

Another object of the present invention is to provide a non-unitarysurgical clip which exerts a constant compressive force along the entireprofile of the surfaces of the clip's clamping elements. The clip ismade of shape memory material which provides a constant compressiveforce over large elongations.

In yet another object of the present invention a surgical compressionclip is provided that produces continuous clamping compression of tissueadjacent to a resected site. The continuous compression is effectedalong a continuous line, thereby preventing undesired post-surgery fluidleakage and bleeding. Such a continuous line is impossible to attainwhen using surgical staples.

It is a further object of the present invention to provide a surgicalcompression clip and a system for applying the clip that reduces therisk of tissue perforation when all tissue layers proximate to a lesionare resected.

The surgical clips described herein may find particular use in varioustypes of resections of a suspect lesion, such lesion arising in, forexample, but without intending to be limiting, the bowel, rectum,appendix, gallbladder, uterus, stomach, esophagus, etc.

In one aspect of the present invention there is provided a surgical clipassembly which comprises a pair of generally linear compression elementsfor securing tissue therebetween and for applying to the secured tissuea compression force. The clip assembly has an initial, open position inwhich the linear compression elements may be positioned about tissue tobe secured between them, and a final, closed position whereat thecompression elements are substantially parallel to each other, therebyto apply a compressive force to the secured tissue. The clip furthercomprises a force means disposed between the pair of compressionelements and operative to transmit operational forces therebetween.

In embodiments of the present invention the force means is typicallyformed of a shape memory material.

In some embodiments of the clip assembly of the present invention, theforce means includes one or more active hinge members disposed betweenthe linear compression elements.

In some embodiments, each of the linear compression elements has firstand second end portions, and the one or more active hinge members aredisposed in proximity to a predetermined one of the first and second endportions.

In some embodiments, the assembly further includes a pair of generallylinear securing elements, wherein each of the linear compressionelements is associated with one of the pair of generally linear securingelements. The securing elements are operative for securing tissue to becompressed by the compression elements and the securing elements andform a securing line when grasping the tissue. The securing line is notcollinear with the line of compressive force produced by the compressionelements. Typically, the securing elements include a gripping portionhaving a serrated profile formed of a plurality of teeth-likeprojections over at least part of the length of the securing elements.The teeth-like projections of the profile are not necessarily uniformlydistributed along the length of the gripping portion although in someembodiments they may be. In some embodiments, the assembly furtherincludes one or more receiving structures sized and configured todisengageably receive an attachment element of a clip applier. The clipapplier exerts a force counter to the force exerted by the one or morehinge members and is operable for bringing the clip assembly from itsclosed position to its open position or vice versa.

In some embodiments of the clip assembly, the pair of securing elementsand the pair of compressing elements are formed from material selectedfrom the group of materials consisting of: an insulative material and aninsulative-coated metal material. In some embodiments, the compressingelements and securing elements are integrally formed with each other. Ininstances where these are not integrally formed, they may be joined by amethod chosen from the group of methods consisting of: welding, gluing,a mechanical clip, fixating joint or a mechanical press.

In another embodiment of the clip assembly, the one or more active hingemembers includes first and second hinge members, disposed in proximityto the first and second end portions, respectively, of the linearcompression elements. In some embodiments the clip assembly may furtherinclude a pair of generally linear securing elements, wherein each ofthe linear compression elements is associated with one of the pair ofgenerally linear securing elements. The securing elements are operativefor securing tissue to be compressed by the compression elements and thesecuring elements forming a securing line when grasping the tissue. Thesecuring line is not collinear with the line of compressive forceproduced by the compression elements. In a further embodiment of theclip assembly of the present invention, the securing elements include agripping portion having a serrated profile formed of a plurality ofteeth-like projections over at least part of the length of the securingelements. In some embodiments, the compressing elements and securingelements are integrally formed with each other. In instances where theyare not integrally formed, they may be joined by a method chosen fromthe group of methods consisting of: welding, gluing, a mechanical clip,fixating joint or a mechanical press.

In an embodiment of the present invention, the first and second hingemembers each has a generally planar body that includes two legs eachhaving an end portion. Each of the hinge members has located at each ofits end portions a connector having a single insertable end portion. Theconnector is positioned substantially transversally to the planar body.The clip assembly further includes a pair of generally linear securingelements, wherein each of the linear compression elements is associatedwith one of the pair of generally linear securing elements. The singleinsertable end portion of the connectors is pivotably connected to thecompression elements, allowing concurrent mechanical communicationbetween the hinge members and the compression elements.

In another embodiment of the clip assembly of the present invention, thefirst and second hinge members each has a generally planar body thatincludes two legs. Each leg has an end portion. Each of the hingemembers has located at each of its end portions a connector having asingle insertable end portion. The connector is positioned substantiallytransversally to the planar body. The clip assembly further includes apair of generally linear securing elements, and each of the linearcompression elements is associated with one of the pair of generallylinear securing elements. The single insertable end portion of theconnectors is pivotably connected to the securing elements, therebyallowing concurrent mechanical communication between the hinge membersand the securing elements.

In yet another embodiment of the clip assembly of the present invention,the first and second hinge members each has a generally planar body thatincludes two legs each having an end portion. Each of the hinge membershas located at each of its end portions a connector having first andsecond insertable end portions. The connectors are positionedsubstantially transversally to the planar body. The clip assemblyfurther includes a pair of generally linear securing elements. Each ofthe linear compression elements is associated with one of the pair ofgenerally linear securing elements. The first end portions of theconnectors of the hinge members is pivotably connected to the securingelements, allowing concurrent mechanical communication between the hingemembers with the two securing elements. The second insertable endportions of the connectors are pivotably connected to the compressingelements, allowing concurrent mechanical communication between the firstand second hinge members and the two compressing elements.

In another embodiment of the clip assembly, the connectors of the firstand second hinge members are joined to the legs of the hinge members onan inner surface of the legs. This produces a preloaded clip assemblywhen the connectors are pivotably connected to one or more of thecompressing elements and one or more of the securing elements.

In yet another embodiment, the clip assembly further includes one ormore gap forming elements positioned on one or more end portions of oneor more compression elements. The gap forming element creates a gapbetween the compression elements when the clip assembly is in its closedposition.

In one embodiment of the present invention, the two legs of the firstand second hinge members are each of the same length. In anotherembodiment of the present invention, the two hinge members are identicalbut the legs of the hinge members are of different lengths.

In a further embodiment of the clip assembly, one of the compressionelements has a hollow tubular structure with an elongated slot at eachof its ends positioned on the side of the one of the compressionelements proximate to the hinge members. A projection translationallyrides in each of the slots and is pivotally connected to the hingeelements and the one compression element mentioned above. When theprojections riding in the slots ride away from each other, the longer ofthe legs of each of the hinge members travel in opposite directions fromeach other. This causes the hinge members to bring the clip assembly toits open position. When the projections ride in the slots towards eachother the longer of the legs of each of the hinge members travel towardeach other causing each of the hinge members to bring the clip assemblyto its closed position.

In yet another embodiment of the clip assembly of the present invention,the clip assembly further includes two joined threaded bolts positionedinside the hollow compression element. Each of the bolts has a differenthandedness and each has a threaded cylinder with an extension fittedthereon. Each of the extensions is pivotably connected to one leg of adifferent one of the hinge members. The extensions are operable as theprojections for riding along the elongated slot when the threaded boltsare rotated. When rotating the joined bolts in one direction, theprojections, being in mechanical communication with the bolts, travel inthe slots in a direction away from each other. This brings the clipassembly to its open position. When rotating the joined bolts in asecond direction, the projections travel in the slots in a directiontoward each other thereby bringing the clip assembly to its closedposition.

In another embodiment of the invention, each of the hinge members has aconnector positioned near the end portion of one of its legs. Theconnector serves as the projection for insertion into andtranslationally riding in the slots. The clip assembly further includeswires connected to the connectors. When the wires are pulled in onedirection the connectors travel in the slots in a direction away fromeach other thereby bringing the clip assembly to its open position. Whenthe wires are released, the connectors travel in the slots in adirection toward each other, bringing the clip assembly to its closedposition.

In another embodiment of the clip assembly, the assembly furtherincludes one or more receiving structures sized and configured todisengageably receive an attachment element of a clip applier. The clipapplier exerts a force counter to the force exerted by the one or morehinge members and is operable for bring the clip assembly from itsclosed position to its open position or vice versa.

In another embodiment of the present invention, the one or more activehinge members includes a single member, disposed in proximity to thefirst end portions of the linear compression elements. When the clipassembly is in the open position, the linear compression elements form ajaws-like arrangement and the second end portions of the linearcompression elements are spaced apart so as to permit positioning of thecompression elements about tissue to be secured therebetween. Ininstances of this embodiment, the single hinge member is fixablyconnected to the first end portions of the linear compression elements.

In other embodiments of the present invention, there is a selectablymovable latch member positioned within a first of the two compressionelements and extending past its second end portion. There is anengagement means on the second end of the second compression element forengaging and holding the latch member in force producing engagement whenthe pair of compression elements are brought close to each other, andwhen the latch member is moved to engage with the engagement means.

In another embodiment of the present invention, the assembly furtherincludes a wire extending between the second end portion of each of thetwo compression elements. The wire is releasably connected to the latchmember and has an extension extending via the second end portion of thesecond compression element through the first compression element. Theextension is operative to draw the wire taut when tissue is positionedbetween the two compressing elements. The taut wire thereby prevents thetissue from moving out from between the pair of compression elementswhile the clip assembly is brought to its closed position.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and its features andadvantages will become apparent to those skilled in the art by referenceto the ensuing description, taken in conjunction with the accompanyingdrawings, in which:

FIG. 1A is an overall isometric view of an endoscopic system constructedaccording to the present invention;

FIG. 1B is an enlarged view of the distal end of the endoscopic systemshown in FIG. 1A;

FIG. 1C is an enlarged view of the proximal end of the endoscopic systemshown in FIG. 1A;

FIG. 2 shows an isometric view of the compression clip constructedaccording to a first embodiment in its closed position;

FIGS. 3A and 3B show isometric top and bottom views of the compressionclip shown in FIG. 2 in its open position;

FIGS. 4A, 4B and 4C show isometric views of different configurations ofspring elements constructed according to various embodiments of thepresent invention;

FIG. 5 is an isometric view of a clip applier constructed according toone embodiment of the present invention, the applier in its closedposition;

FIG. 6 is an isometric view of the clip applier in FIG. 5, the applierin its open position;

FIG. 7 is an isometric view of the clip applier in FIG. 5 without itsbase element, the applier in its open position;

FIG. 8 is an isometric view of the clip applier of FIG. 5 used toposition the clip in FIG. 2, the clip being attached to the applier andin its closed position;

FIG. 9 is an isometric view of a clip applier used to position the clipin FIG. 2, the clip being attached to the applier and in its openposition;

FIG. 10 is an isometric view of a clip applier constructed according toa second embodiment of the present invention, the applier in its closedposition;

FIG. 11 is an isometric view of the clip applier in FIG. 10, the applierin its open position;

FIG. 12 is an isometric view of the clip applier of FIG. 10, attached toa clip constructed as in FIG. 2, the clip being attached to the applierand in its closed position;

FIG. 13 is an isometric view of the clip applier of FIG. 10, attached toa clip constructed as in FIG. 2, the clip being attached to the applierand in its open position;

FIGS. 14 and 15 show isometric views of a second embodiment of asurgical compression clip constructed according to the presentinvention, wherein FIG. 14 and FIG. 15 show the clip in its closed andopen positions, respectively;

FIG. 16 shows an exploded view of the clip in FIGS. 14 and 15;

FIGS. 17 and 18 show isometric partially cut-away views of thecompression clip shown in FIGS. 14 and 15, respectively;

FIGS. 19 and 20 show isometric views of a clip applier used with theclip shown in FIGS. 14-18, FIG. 19 showing the applier engaged to theclip and FIG. 20 disengaged from the clip;

FIG. 21 shows an isometric view of the applier in FIGS. 19 and 20;

FIG. 22 shows a partially exploded view of the applier in FIGS. 19 and20;

FIG. 23 shows a cross-sectional view of the applier shown in FIGS. 19and 20;

FIG. 24A shows an exploded view of a third embodiment of a compressionclip constructed according to the present invention;

FIG. 24B shows an isometric partially cut-away view of the clip shown inFIG. 24A;

FIGS. 25A and 25B are an isometric top and bottom view of a clipconstructed according to a fourth embodiment of the present invention,the clip being in its closed position;

FIGS. 26A and 26B are an isometric top and bottom view of a clipconstructed according to the embodiment of FIGS. 25A and 25B, the clipbeing in its open position;

FIGS. 27A and 27B are isometric views of a clip applier constructedaccording to another embodiment of the present invention, the appliershown in its closed and open position, respectively;

FIGS. 27C and 27D are cross-sectional views of the clip applier shown inFIGS. 27A and 27B, the applier shown in its closed and open position,respectively;

FIGS. 28A and 28B are isometric views of the clip applier shown in FIGS.27A and 27B constructed in its closed and open position, respectively,when attached to and operating the clip shown in FIGS. 25A-26B;

FIG. 29 is an exploded view of another embodiment of a clip applier foruse with the clips in the specification herein;

FIGS. 30A and 30B are isometric views of the clip applier shown in FIG.29 in its closed and open position, respectively;

FIG. 30C is a revealed inner view of FIG. 30B;

FIG. 31A is a cross-sectional view of a surgical compression clipconstructed according to a fifth clip embodiment of the presentinvention, the clip being in its open position and attached to itsassociated applier;

FIG. 31B is an enlarged view of a portion of the distal end of the clipshown in FIG. 31A;

FIGS. 32 and 33 are different partially exploded views of the surgicalcompression clip and applier in FIG. 31A;

FIG. 34 shows different views of the shape memory spring element of theclip in FIG. 31A;

FIG. 35 shows different views of the latch arm of the clip presented inFIG. 31A;

FIG. 36 shows an isometric view of the clip's spring element at thehinge region of the clip shown in FIG. 31A;

FIG. 37 shows an isometric front side view of the clip in FIG. 31A, theclip in its open position;

FIGS. 38 and 39 show different views of the clip in FIG. 31A where thewire of the clip has been drawn taut;

FIG. 40 shows an enlarged view of the clip shown in FIG. 31A includingthe clip's distal end and its locking process;

FIG. 41 shows an enlarged cross-sectional view of the distal end of theclip shown in FIG. 31A, the clip in its latched position;

FIGS. 42 and 43 show additional enlarged views of the distal end of theclip shown in FIG. 31A, the clip being in its closed position;

FIG. 44 shows an isometric view of the clip shown in FIG. 31A, the clipin its closed position and ready for insertion into a clip applier;

FIG. 45 shows an endoscope prior to insertion into a multi-lumen sleeve;

FIG. 46 shows the endoscope of FIG. 45 being inserted into a multi-lumensleeve;

FIG. 47A shows the endoscope after insertion into the multi-lumensleeve;

FIG. 47B shows an enlarged view of the distal end of the endoscope inFIG. 47A;

FIG. 48 shows the sleeve-encased endoscope as it approaches a polyp inthe gastrointestinal tract;

FIG. 49 shows a view of a surgical clip attached to an applier beingadvanced to the site of the polyp through a secondary lumen of thesleeve;

FIG. 50 shows a top side view of the surgical clip attached to anapplier being positioned proximate to the polyp;

FIG. 51 shows a top side view of a surgical clip and applier positionedproximate to a polyp and a grasper assembly being positioned proximateto the polyp after advancing through a working channel of the endoscope;

FIG. 52 shows a top side view of the opened clip proximate to the polyp;

FIG. 53 shows a top view of the grasper of the grasper assemblybeginning to pull the polyp through the opened clip shown in FIG. 52;

FIG. 54 shows a top side view of the grasper of the grasper assemblygrasping the polyp;

FIG. 55 shows a top side view of the grasper continuing to pull thepolyp through the opened surgical clip;

FIG. 56 shows a top side view of the grasper and grasper transportingelement rotating and wrapping the pulled polyp around the graspertransporting element;

FIG. 57 shows a cross-sectional view along line AA′ of FIG. 56 of thegrasper and grasper transporting element rotating and wrapping thepulled polyp around the grasper transporting element;

FIG. 58 shows a top side view of the surgical clip closing around thewrapped polyp;

FIG. 59 shows a top side view of the closed surgical clip and polypwithout the applier that has been withdrawn through a secondary lumenfrom the region of the resected polyp;

FIG. 60 shows a top side view of the closed surgical clip and polyp witha severing device approaching the rotated polyp for severing;

FIG. 61 shows a top side view of the tissue held by the clip at theresection site; and

FIGS. 62A and 62B show two side views of the tissue held by the clip atthe resection site.

Similar elements in the Figures are numbered with similar referencenumerals.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present application should be read in conjunction with co-pending USapplication “Endoscopic Full Thickness Resection Using SurgicalCompression Clips”, attorney's docket number 41758, filed by the sameapplicant and inventors concurrently on Dec. 29, 2006. This document isherein incorporated by reference in its entirety.

The present invention describes non-unitary surgical compression clips,which lessen the likelihood of internal leakage of bodily fluids whichoften occurs when staple suturing is used. These clips, when used, alsolessen the likelihood of bleeding and do not leave any permanent foreignbody inside the body cavity after tissue closure and healing iscomplete.

The non-unitary, i.e. compound, surgical compression clips describedherein, typically have one or more elements, generally two or moreelements, made of a shape memory material, such as a nickel-titanium(Ni—Ti) alloys. The clip includes two compressing elements connectedoperationally by at least one of the shape memory elements. Typically,the clip also includes securing elements with which to hold the tissuebeing compressed. Also typically, the compressing elements are linear asare the securing elements. When tissue to be joined is held between thetwo compressing elements, a constant compressive force acts between thetwo elements, these latter being connected at both of their ends by theshape memory elements. The constant force is a result of thewell-documented long plateau region of the shape memory material'sstress-strain hysteresis curve. In this plateau region, the force isconstant irrespective of the extent of the deformation. This is aconsequence of properties exhibited by shape memory materials.Additionally, stress-induced strain is recoverable in these materials;in the case of nitinol, 6-8% of the strain can be recovered.

Discussions of the stress-strain curves of shape memory materials andits stress induced strain can be found in many publications. See forexample “Shape Memory Materials”, edited by K. Otsuka and C. M. Wayman,Cambridge University Press 1998, p. 62 and; H. Tobushi et al in“Deformation Behaviour of Ni—Ti Superelastic Alloy Subjected to StrainVariation” in SMST-94: The Proceeding of the International Conference onShape Memory and Superelastic Technology, edited by A. Pelton, D. Hodsonand T. Duerig, 1995, pp. 389-391.

It should be noted that the line of compressive force produced by thecompression elements of the clips of the present invention is notcollinear with the line exerted by the securing elements on the tissueto be resected. These are two different lines of action, separated by adistance. Were they to be co-linear the healing of the tissue at thecompression site may be compromised. Additionally the arrangement ofnon-colinearity allows for more homogeneous tissue compression by thecompression elements. Any penetration of the teeth for securing thetissue is compensated for by the continuous compression line moreproximate to the body cavity wall.

The shape memory elements, which act as force appliers, are typicallymade of nickel-titanium (Ni—Ti) alloys but other shape memory materialsmay also be used. The other elements of the clip, i.e. the compressingelements and the securing elements (and possibly separate toothedelements for attachment to the securing elements when there is nointegrally formed toothed edge on the securing elements) may also bemade of a shape memory material such as a nitinol alloy, but that is notessential. Other metals or alloys, such as stainless steel or othertitanium alloys, and even certain plastic materials may also be used.The compression clips described herein are typically attached to anapplier and brought to tissue adjacent to a resection site, or to tissueadjacent to a perforation to be joined, or to any tissue having anopening requiring closure.

It should be noted that the line of compressive force produced by thecompression elements of the clips of the present invention is notcollinear with the line exerted by the securing elements on the tissueto be resected and/or closed. These are two different lines of action,separated by a distance. Were they to be co-linear the clip could easilydisengage before scar tissue matured at the compression site.Additionally, the non-collinear arrangement allows for more homogeneoustissue compression by the compression elements. Furthermore, anypenetration of the teeth on the securing elements for securing thetissue is compensated for by the clip's continuous compression linebeing further away from the resected site or the opening to be closed.

The surgical clips described herein may be used with standardcommercially available endoscopes. Dedicated or specially designedendoscopes can be used but are not necessary.

Additionally, using the compression clips of the present invention isnot limited to any particular direction or shape of resection incision;both radial and longitudinal incisions are contemplated by the presentinvention.

The surgical clips described herein have additional advantages. Thecompression force ensures continuous compression of the tissue at theresected site, independent of the variation in tissue thickness. Noforeign bodies are left behind in the body cavity as the clip istypically self-evacuating. Finally, since the invention makes use ofshape memory materials, the clip may be of relatively small dimensionsand there is no need for large instruments, such as currently employedstapler firing mechanisms. This permits easier advance of the clip andits applier to a site requiring closure.

Before explaining several embodiments of the invention in detail, it isto be understood that the invention is not limited in its application tothe details of construction and the arrangement of the components setforth in the following description or illustrated in the drawings. Theinvention is capable of other embodiments or of being practiced orcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein is for the purpose ofdescription and should not be regarded as limiting.

FIGS. 1A-1C, to which reference is now made, show an overall view of anendoscopic system constructed according to the present invention, anenlarged view of the system's distal end F and an enlarged view of thesystem's proximal end N, respectively.

FIG. 1A includes an endoscope insertion shaft 300 encased in amulti-lumen sleeve 150. At the distal end F of endoscope insertion shaft300, working instruments constructed according to the present inventionmay exit. These instruments include a surgical clip 10 attached to anapplier 30 and a grasper assembly 200 including a grasper transportingelement 260. These instruments are inserted into a working channel 154of endoscope insertion shaft 300 or one or more secondary lumens 158 ofsleeve 150. Insertion of the instruments is effected at the proximal endN of endoscope insertion shaft 300. They are advanced in the directionof, and ultimately exit at, or adjacent to, the distal end F ofendoscope insertion shaft 300. Actuators 306 and 308 may be any of manyknown to those skilled in the art. They can apply one or a combinationof control actions or movements, such as pull and release, articulation,swivel and the like. Endoscope insertion shaft 300 is typicallyconnected to a fiberoptic cable 304 which communicates images to avisual display 302.

Details of the instruments used, the multi-lumen sleeve and otherspecific aspects of the system of the present invention are furtherdiscussed below.

Reference is now made to FIGS. 2-3B where FIG. 2 presents a view of anon-unitary compression clip constructed according to a first embodimentof the present invention. In FIG. 2 the clip is shown in its closedposition. FIGS. 3A and 3B present a view of the compression clip shownin FIG. 2 in its open position.

Clip 10 is constructed of two shape memory hinge springs 12A and 12B,also herein often denoted as force appliers. Typically, but withoutintending to be limiting, the shape memory material is a Ni—Ti alloy.The operation of the clip relies on shape memory effects exhibited bythese materials. Springs 12A and 12B may be made of a single wire orflattened wire or strip or it may be constructed of two or more wires,flattened wires or strips connected together at their ends. Furthermore,in some embodiments, the springs may be constructed to have a coiledshape.

Clip 10 further includes two securing elements 14A and 14B, each ofwhich has a series of teeth 20 for grasping tissue. Each of securingelements 14A and 14B may be formed from a single piece or weldedtogether from several pieces, typically but without intending to belimiting, of metal. Teeth 20 may be formed integrally with elements 14Aand 14B or they may be joined to the elements, for example, by welding.Generally, these securing elements are made of metal and typically arewelded or otherwise joined to two metal compressing elements 16A and16B. However, the securing elements and the compressing elements may bejoined together by any method known to those skilled in the art.Securing elements 14A and 14B may also be formed integrally withcompressing elements 16A and 16B, respectively.

Securing elements 14A and 14B are formed with spacings 18 configured andsized to receive the pushing elements of a clip applier (not shown).Compressing elements 16A and 16B, typically, but without intending to belimiting, are cylindrically-shaped. These include holes 19 (best seen inFIG. 3B) into which connectors 17 (also best seen in FIG. 3B) of hingesprings 1-2A and 12B are insertable. Insertion of hinge springs 12A and12B occurs prior to welding or otherwise joining toothed securingelements 14A and 14B to compressing elements 16A and 16B, respectively.As a result of the weld or other joining method, securing elements 14Aand 14B prevent connectors 17 of hinge springs 12A and 12B from droppingout of holes 19. Securing elements 14A and 14B, and compressing elements16A and 16B are joined together by hinge springs using any method knownto those skilled in the art, particularly in the art of articulationhinges (swing joints). The natural tension of hinge springs 12A and 12Boperates to keep compressing elements 16A and 16B in their closedposition as in FIG. 2.

The metal used for forming securing elements 14A and 14B, compressingelements 16A and 16B and teeth 20, if these latter are made fromseparate pieces and welded to elements 14A and 14B, should be a rigidmetal such as, but without being limiting, stainless steel.

While in the above embodiment, securing elements 14A and 14B are weldedto compressing elements 16A and 16B, respectively, in other embodimentsthis need not be the case. The securing and compressing elements may bejoined to each other by mechanical means such as by U-shaped elementspositioned on securing elements 14A and 14B. clippably engageable tocompressing elements 16A and 16B or by press connections wherein an edgeon each of securing elements 14A and 14B would be pressed to enter aslit in their respective compressing elements 16A and 16B.Alternatively, securing elements 14A and 14B and compressing elements16A and 16B can be crimped together.

In other embodiments, securing elements 14A and 14B and compressingelements 16A and 16B may be made of a single piece of plastic, forexample by ejection molding. In such embodiments, only hinge springs 12Aand 12B are made of metal, specifically a shape memory metal or alloy,typically but without intending to be limiting, a Ni—Ti alloy. In suchplastic embodiments, hinge springs 12A and 12B (force appliers) wouldtypically be snapped into place between securing elements 14A and 14Band compressing elements 16A and 16B. However, it is evident to oneskilled in the art that other methods of introducing the metal hingesprings 12A and 12B could also be used.

Clip 10 in its closed position appears as shown in FIG. 2. Hinge springs12A and 12B exert no force when the clip is fully closed, i.e. whencompressing elements 16A and 16B lie proximate and tangent to eachother. However, as compressing elements 16A and 16B are separated apart,hinge springs 12A and 12B exert a force which tries to bring compressingelements 16A and 16B and securing elements 14A and 14B together. Whenclip 10 is to be opened, pushing elements of a clip applier (not shown)may be positioned and wedged between teeth 20 of securing elements 14Aand 14B or they may be positioned in a spacing or indentation 18. Theapplier is activated to apply a force via its pushing elements (notshown). This force opposes the force exerted by hinge springs 12A and12B. This counter force spreads securing elements 14A and 14B andcompressing elements 16A and 16B apart. It also spreads hinge springs12A and 12B as in FIGS. 3A and 3B.

After tissue is brought to and positioned between the separatedcompressing elements 16A and 16B, the applier is operated to relax theapplied force allowing securing elements 14A and 14B to move toward eachother and to return to their original closed position (FIG. 2). Shapememory hinge springs 12A and 12B also relax and return to their originalshape. The tissue positioned between the securing and compressingelements of clip 10 prevents compressing elements 16A and 16B andsprings 12A and 12B from completely returning to their original closedpositions. Once the compressing elements are stopped by the tissue,continued closure of the applier's pushing elements leads to separationof the pushing elements of the applier from securing elements 14A and14B of clip 10. This, in turn, causes the applier to disengage from clip10.

While the shape memory elements used to effect opening or closing ofclip 10 are here described as hinge springs, these elements can moregenerally be classified as force appliers. Therefore, it should beunderstood that elements of any shape which can generate a force foreither opening or closing a compression clip may be used and theseelements can and will often be denoted herein as force appliers.

In other embodiments, pushing elements of a clip applier are insertedinto special indentations in securing elements 14A and 14B. Thespacing/indentation is best seen as element 718 in FIGS. 25A and 26Adiscussed below. In yet another embodiment, when pushing securingelements 14A and 14B, the pushing elements of an applier (not shown) areinserted and loosely held in holes (not shown) positioned on securingelements 14A and 14B.

Shape memory hinge springs 12A and 12B can have distinctive connectors17 at their ends as shown in FIGS. 4A-4C. A hinge spring havinguni-directional connectors 17 is shown in FIG. 4A. However, the use ofhinge springs with bi-directional connectors 17′ as shown in FIG. 4B isadvantageous over the uni-directional connectors 17 shown in FIG. 4A.The hinge spring's bi-directionality allows connectors 17′ to beinserted simultaneously into holes 21 in securing elements 14A and 14Band into holes 19 in compressing elements 16A and 16B. This increasesstability of the clip 10. It also reduces the chance that hinge springs12A and 12B will be displaced during operation of the clip and interferewith closure of the clip. The positioning of hinge springs 12A and 12Bwith connectors 17′ can readily be seen in FIGS. 2, 3A and 3B where clip10, in its closed and open positions, is shown. Reference to the use ofhinge springs with connectors of the type of connector 717 shown in FIG.4C will be made later in the text.

Connectors 17, 17′ and 717 shown in FIGS. 4A, 4B and 4C respectivelyform articulating joints when they are inserted into correspondingapertures or holes in compression elements and/or securing elements asdescribed in the first through fourth compression clip embodimentsdescribed below. These connectors rotate or swing in their respectiveapertures and holes allowing for articulation.

It should be noted that as in clip 10 of FIGS. 2-3B, in some embodimentsteeth 20 do not necessarily extend the entire length of securing element14A and 14B while in others they do. Additionally, it should be notedthat in some embodiments of clip 10 in FIGS. 2-3B, teeth 20 need not bedistributed uniformly along securing elements 14A and 14B. Additionally,at both ends of elements 14A and 14B there is a small bend 22 welded orotherwise joined to the sides. In some embodiments, bend 22 may beintegrally formed as part of elements 14A and 14B. This provides extrasecurity against clip 10 slipping off the compressed suspect tissueduring resection.

In the compression clip embodiments shown in FIGS. 2-3B and as discussedelsewhere in this specification, the securing elements and theirrespective compressing elements have been described as separateelements. In their operational state within the clips, these aretypically a single joined element reflecting a single part and may bethought of as such. In the joined part, the securing elements attach toand grip the tissue to be resected while the compressing elements act topress the parts of the resected site together even when they are formedas separate elements and are only later joined together to operate as asingle part.

Reference is now made to FIGS. 5-9 where various views of a firstembodiment of a clip applier are shown. The clip applier may be usedwith surgical compression clip 10 shown in and described in conjunctionwith FIGS. 2-3B.

FIG. 5 shows clip-applier 30 in its closed position. Clip applier 30 iscomprised of applier arms 34A and 34B, applier base 32, and connectorelements 36A and 36B. The elements of clip applier 30 are typicallyconstructed of stainless steel but they may also be constructed of othermetals, such as, but not limited to, titanium, titanium alloys orreinforced plastics.

As best seen in FIG. 6 where clip applier 30 is shown in it openposition, each of applier arms 34A and 34B has, at its distal end, aninsertion projection 38A and 38B, respectively. Insertion projections38A and 38B are formed substantially transverse to applier arms 34A and34B and are operative for insertion between teeth 20 of securingelements 14A and 14B in FIG. 2, or into indentations 718 of clip 710 inFIG. 25A, or alternatively into holes positioned in securing elements14A and 14B and compressing elements 16A and 16B.

FIG. 7 shows open clip applier 30 without its applier base 32.

As seen in FIGS. 5 and 6, applier base 32 has a generally barrel-likeshape from which emerges a pair of applier base projections 31. Each ofthese projections 31 has an applier base slot 45 and an applier baseprojection hole 37. Each of applier arms 34A and 34B has at its proximalend applier arm slots 40A and 40B and applier arm holes (not shown).Applier arm 34B is constructed with a bend 35 in it so that the distalportions of arm 34B and arm 34A can lie in the same plane. It alsoallows insertion projections 38A and 38B to lie in the same plane.

Each of connector elements 36A and 36B has a pair of holes 41A-41D (41Cand 41D not visible), one at each end of each element.

Applier arms 34A and 34B are joined to applier base 32 by connecting pin43 which passes through applier base projection holes 37 and applier armholes (not shown). Pin 42 is inserted into holes (not shown) inconnector elements 36A and 36B and is movable in applier base slots 45and applier arm slots 40A and 40B. As pin 42 moves it forces applier armslots 40A and 40B to overlap with applier base slots 45 at the point ofthe pin, thus creating an opening and closing effect.

The proximal ends of connector elements 36B and 36A, respectively, areattached to an operating cable (not shown) that exits the proximate endof the endoscope. The cable is activated by an actuator 306 (FIG. 1A),for example, positioned outside the proximal end N (FIG. 1A) of theendoscope.

FIG. 8 and FIG. 9 show clip applier 30 of the present embodimentattached to surgical compression clip 10 described in FIGS. 2-3B in itsclosed and open position, respectively.

To open clip applier 30, an operating cable (not visible) pullsconnector elements 36A and 36B in the proximal direction. Concurrently,pin 42 moves to the proximal end of applier base slots 45 and theproximal ends of applier arm slots 40A and 40B. In that position,applier arms 34A and 34B move apart as in FIG. 9.

To close clip applier 30, the tension in the operating cable (notvisible) is released. In doing so, the force that hinge springs 12A and12B exert is greater than that of the operating cable. A force is thusexerted on applier arms 34A and 34B through securing elements 14A and14B. The clip's force brings applier arms 34A and 34B together, whichpushes connector elements 36A and 36B in the distal direction.Concurrently, pin 42 moves to the distal end of applier base slots 45and the distal ends of applier arm slots 40A and 40B. In that position,applier arms 34A and 34B move together as in FIG. 8.

When applier arms 34A and 34B are pushed apart as in FIG. 9, insertionprojections 38A and 38B of clip applier 30 push against the spacingsbetween teeth 20 of securing elements 14A and 14B of clip 10 shown inFIG. 2 (or indentations 718 of clip 710 shown in and discussed below inconjunction with FIGS. 26A and 26B) so that securing elements 14A and14B and compressing elements 16A and 16B of clip 10 move apart. Whenapplier arms 34A and 34B are moved together as in FIG. 8, insertionprojections 38A and 38B of clip applier 30 exert a reduced force on thespacings between the teeth 20 of securing elements 14A and 14B of clip10 in. FIG. 2 (or on indentions 718 of clip 710 shown in and discussedin conjunction with FIGS. 26A and 26B) so that securing elements 14A and14B and compressing elements 16A and 16B of clip 10 move together. Thecounter force exerted by hinge springs 12A and 12B keeps clip applier 30in place. Once tension generated by springs 12A and 12B is reducedsufficiently, that is as clip 10 closes on and compresses tissue,insertion projections 38A and 38B of applier 30 essentially fall awayand disengage from clip 10.

FIGS. 10-13, to which reference is now made, show various views of asecond embodiment of a clip applier constructed according to the presentinvention. The applier is intended for use with the surgical compressionclip (slightly modified as discussed below) shown in and discussed inconjunction with FIGS. 2-3B. FIG. 10 shows the clip applier in itsclosed position, while FIG. 11 shows the applier in its open position.

Turning to FIG. 11 first, clip applier 50 includes insertion links 60Aand 60B which are swing jointed by links 62A, 62B, 64A, 64B and centralbar 66. An operating cable (not shown) is connected to the proximal endof central bar 66 and inserted into spring 52. The latter connection canbe achieved by welding or any other connecting method or means known tothose skilled in the art.

Insertion links 60A and 60B each have extensions (not shown) which arepositioned on their distal end so that these extensions are insertableinto cylindrical elements 58A and 58B. As shown in FIGS. 12 and 13,cylindrical elements 58A and 58B (best seen in FIGS. 10 and 11) arethemselves insertable into the ends of compressing elements 16A and 16Bof a surgical compression clip similar to clip 10 discussed above inconjunction with FIGS. 2-3B.

Compressing elements 16A and 16B, as shown in FIGS. 2-3B, require aslight modification to be compatible with cylindrical elements 58A and58B of clip applier 50. To be compatible, at least one of the ends ofelements 16A and 16B should be hollow and tubular so that cylindricalelements 58A and 58B of clip applier 50 can be inserted into them.

While in the embodiment shown in FIG. 10 and FIG. 11, cylindricalelements 58A and 58B are separate elements, in other embodiments theymay be integrally formed at the ends of insertion links 60A and 60B.

FIGS. 10 and 11 show assembled clip applier 50 in its closed and openpositions, respectively. FIGS. 12 and 13 show clip applier 50 insertedinto compressing elements 16A and 16B of surgical compression clip 10when the clip is in its closed and open positions, respectively.

Moving from the open to the closed position of clip applier 50 (or viceversa), and therefore to the open or closed position of clip 10 (or viceversa), can be effected using an operating cable (not shown) joined to,or in other ways in direct communication with, central bar 66 (FIG. 11).The cable passes through spring 52 and out of the proximal end N (FIG.1A) of the endoscope where it is activated by a user employing anactuator (schematically shown as element 306 of FIG. 1A). The actuatormay be any of several types known to those skilled in the art.

Spring 52, in addition to protecting the cable (not shown), serves as astop sleeve for element 56 while pulling the cable thus enabling theseparation of insertion links 60A and 60B. In addition, it allows forgreater flexibility of the apparatus as it advances through a lumen of amulti-lumen sleeve (or an endoscopic working channel) from the proximalend of the endoscope toward the suspect lesion near the distal end ofthe endoscope. Alternatively, the cable can be covered and protected bya flexible tube. The tube may be formed of polytetrafluoroethylene(PTFE), but the choice of this material is exemplary only and it is notintended to be limiting.

To open clip applier 50, central bar 66 is pulled by the operating cable(not shown) in the proximal direction. When that occurs, interconnectlinks 62A and 62B and 64A and 64B and insertion links 60A and 60B moveapart as in FIG. 11 due to the moment exerted on links 64A and 64B. Wheninsertion links 60A and 60B are inserted into clip 10 as in FIG. 12,clip 10 also opens as shown in FIG. 13 because of the force exerted byinsertion links 60A and 60B and their attached cylindrical elements 58Aand 58B-on compressing elements 16A and 16B.

During insertion of clip 10 into a body cavity, the clip is attached toclip applier 50 and both clip 10 and applier 50 are advanced, in theirclosed positions, through a secondary lumen of a multi-lumen sleeve (orthrough a working channel of the endoscope shaft). A tension ismaintained in the operating cable (not shown) in order to keep clip 10attached to clip applier 50 during the entire advance from the proximalend of the secondary lumen (or working channel) to its distal end. Thetension in the cable or wire, acts against the force of hinge springs12A and 12B of clip 10. This creates a force between cylindricalelements 58A and 58B of applier 50 and compressing elements 16A and 16Bof clip 10 preventing detachment of clip 10 from applier 50. This forceis smaller than the force required to open clip applier 50 and clip 10attached to it.

To close clip applier 50, the tension in the wire/cable (not shown)passing through spring 52 is released. The force of hinge springs 12Aand 12B is passed through compressing elements 16A and 16B to insertionlinks 60A and 60B. This force applies a moment on links 64A and 64B,which is opposite in direction to the moment exerted when pulling thewire/cable passing through spring 52. When that occurs interconnectlinks 62A and 62B and 64A and 64B and insertion links 60A and 60B movetogether as in FIG. 10. When they move together with clip 10 attached asin FIG. 12, compressing elements 16A and 16B also move together as shownin FIG. 12.

While completely releasing the tension in the pull wire allows for theapplier to fully return to its original closed position, the tissuepulled and held within clip 10 prevents the clip from following theapplier and fully returning to its original closed position. When thisoccurs, cylindrical elements 58A and 58B easily disengage from clip 10since the hinge springs' 12A and 12B force is acting essentially on thetissue instead of on the applier.

A second embodiment of a compression clip 510 constructed according tothe present invention is shown in FIGS. 14-18, to which reference is nowmade. FIGS. 14 and 15 show clip 510 in its closed and open position,respectively. FIG. 16 is an exploded view of the clip and discussion ofthe clip will be made in conjunction with that Figure. Most of theelements in FIGS. 14-18 are the same as those discussed in conjunctionwith the clip embodiments shown in FIGS. 2-3B. Elements that areessentially equivalent in structure and operation will not be discussedagain. Only new elements or structural features will be described.Essentially identical or equivalent elements in the embodiments havebeen numbered as in clips 10 with the addition of 500 as a prefix.

In clip 510, hinge springs 512A and 512B are not symmetrical, eachhaving legs which are of different lengths. Legs 508A and 508B arelonger than legs 509A and 509B. Bi-directional connectors 517 are formedat the end of legs 509A and 509B. These connectors formed substantiallytransversally to the body of clip 510 are sized and configured to beinserted into holes 521 on securing element 514A and holes 519 oncompressing element 516A. At the end of legs 508A and 508B are hollowcylinders 532A and 532B insertable over projections 530, more fullydescribed below.

While compressing element 516A is configured essentially as in FIGS.2-3B, compressing element 516B is a hollow tubular rod with two slots538 on its surface proximal to securing element 514B. Inside compressingelement 516B, a rod, formed of two connected threaded bolts 536A and536B, is positioned. The length of each threaded bolt is less than halfthe length of the rod, with the bolts separated by connector means 540.Threaded bolts 536A and 536B each have different “handedness”, that isthread direction. Because the two threaded bolts have different“handedness” they separate when turned in one direction and come closertogether when turned in the opposite direction.

Over the ends of threaded bolts 536A and 536B are fitted cylindricalelements 528, the latter having complementary threads on their innersurface. Threaded bolts 536A and 536B have an attachment means 534A and534B on their ends for insertion and joining with cylindrical elements528. Cylindrical elements 528 are each formed with a projection 530protruding substantially transversally to the long axis of cylindricalelements 528. Projections 530 pass through slots 538 preventing fittedcylindrical elements 528 from turning as threaded bolts 536A and 536Bare turned. This forces cylinders 528 to move linearly along the longaxis of compression element 516B. The threaded rod with cylinders 528are held to compressing element 516B by plugs 526. Plug 526 on one sideof the rod, the proximal side, includes a recess 524, typically, butwithout being limiting, a square recess, which is configured to receivea screw rotation apparatus (not shown). Projections 530 on cylindricalelements 528 are configured and sized to be inserted into hollowcylinders 532A and 532B formed on the longer legs 508A and 508B ofsprings 512A and 512B. The placement of legs 508A and 508B of hingesprings 512A and 512B and the relationship between plugs 526,cylindrical elements 528 and threaded bolts 536A and 536B (which whenjoined form the threaded rod discussed above) are best seen in FIGS. 17and 18.

Reference is now made to FIGS. 19-23 which show a clip applier 550 thatcan be used to operate clip 510, the latter described in conjunctionwith FIGS. 14-18. FIGS. 19 and 20 show clip applier 550 in its engagedand disengaged position, respectively, with clip 510.

The structure and operation of clip applier 550 can best be understoodby viewing FIGS. 21-23. A cable 552 capable of being rotated is extendedthrough a tube 554, typically a flexible plastic tube capable ofadvancing the clip to the distal end of an endoscope. Cable 552 ends atrotation head 558 which includes a washer element 560 and a male element562, the latter sized and configured for insertion into recess 524 ofclip 510 (FIGS. 14-18).

In some embodiments, tube 554 may be a spring having sufficientflexibility to advance a clip attached to applier 550 past the distalend of the endoscope.

Clip 510, for example, is inserted into a cup 556 of clip applier 550.Cup 556 typically is made of plastic or metal. Plug 526 with recess 524(FIGS. 14-18) is positioned proximate to applier 550. Male element 562is inserted into recess 524 of clip 510. Recess 524 and male element 562are configured to be mateable. Moving clip 510 forward or backward iseffected by pushing or pulling cable 552. Rotating cable 552 opens andcloses the clip depending on the direction of rotation and the sequenceof the bolts and the “handedness” of the threaded bolt proximate to maleelement 562.

Pushing forward releases clip 510 from applier 550. First, washerelement 560 pushes clip 510 out of cup 556. Then, by pulling cable 552towards the proximal end of the endoscope, male element 562 is releasedfrom recess 524 of clip 510, thereby fully releasing the clip from theapplier.

A third embodiment of a compression clip constructed according to thepresent invention is shown in FIGS. 24A and 24B, to which reference isnow made.

From FIG. 24A, which shows an exploded view of clip 610, it is readilyapparent that many of the elements presented there have been encounteredand described previously in conjunction with previously discussedembodiments of compression clips constructed according to the presentinvention. Accordingly, elements that are structurally and operationallysimilar to previously described elements will not be described againhere. Essentially identical or equivalent elements to those found inclips 10 and 510 have been numbered as in clips 10 and 510 with theprefix 600.

Securing and compressing elements 614A, 614B and 616A, 616B,respectively, are essentially the same as in clip 510. Hinge springs612A and 612B are unsymmetrical as in clip 510. Again, there is abi-directional connector 617 on the shorter legs 609A and 609B of hingesprings 612A and 612B which are inserted into holes 621 in securingelement 614A and holes 619 on compressing element 616A. Compressingelement 616B is again a hollow tubular member with two slots 638. Thelonger legs 608A and 608B of hinge springs 612A and 612B includeunidirectional connectors 624 at their ends which extend in thedirection of compressing element 616B allowing for insertion intopreformed holes 630 of cylindrical elements 628, to be discussed below.

Cylindrical elements 628, formed with holes 630, are insertable into andretained in hollow tubular compressing element 616B. Holes 630 ofcylindrical elements 628 act as receiving recesses for connectors 624 ofsprings 612A and 612B. When connectors 624 are inserted into holes 630they are movable in slots 638 and do so with the opening and closing ofsprings 612A and 612B. Tubular compressing element 616B is capped byplugs 626. The plug 626 distal to the user has a hole into which pin 634is inserted.

Passing through tubular compressing member 616B are wires 639A and 639B.These wires have loops 640A and 640B at their ends configured to fitover connectors 624.

Upon viewing FIG. 24B, the arrangement of the various elements of clip610 and their operation becomes evident. In FIG. 24B, clip 610 has beenflipped vis-a-vis the view shown in FIG. 24A and compressing element616B and securing element 614B are not presented. By pulling the ends Eof wires 639A and 639B in the direction of the arrow shown, legs 608Aand 608B of springs 612A and 612B separate as do securing elements 614Aand 614B (the latter not shown) and compressing elements 616A and 616B(the latter not shown). One of the wires in the Figure, wire 639B,passes around pin 634 when pulled. When wires 639A and 639B arereleased, or pushed in a direction opposite to that shown by the arrow,the clip's elements—its securing elements, compressing elements, and thelegs of its springs—move to a position adjacent to each other with thetissue to be resected held between the securing and compressingelements.

After severance of the suspect tissue is effected, excess wire is cutand withdrawn from the endoscope and body.

A fourth embodiment of a surgical compression clip constructed accordingto the present invention is shown in FIGS. 25A-26B, to which referenceis now made.

This embodiment is very similar to the embodiment shown in FIGS. 2-3Band elements are numbered similarly with the inclusion of a prefix digit7. Similar elements are constructed and operative as in the embodimentpresented in FIGS. 2-3B and, accordingly, will not be discussed again.

The present embodiment is different from the embodiment of FIGS. 2-3B inthat the bi-directional hinge spring connectors 717 are now joined onthe inside of hinge spring arms 708 of spring elements 712A and 712B(best seen in FIG. 4C) and not at the ends of hinge spring arms 8 ofhinge spring elements 12A and 12B as in FIGS. 2-3B and FIGS. 4A and 4B.Additionally, and as a direct result of the new positioning of hingespring connectors 717, spaces 725 must be formed in lateral walls 727 ofsecuring elements 714A and 714B. These spaces are absent in walls 27 ofsecuring elements 14A and 14B as seen and labeled in FIG. 3B. Itsnecessity with the present clip embodiment is readily seen in FIGS. 25A,25B, 26A and 26B where hinge spring arms project, at least partially,through spaces 725. It should be noted that securing elements 714A and714B may be a single integral structure or elements made from severalparts joined together by any process known to those skilled in the art,such as by welding. This is true as well for the securing elements shownin previous embodiments and discussed elsewhere herein.

The positioning of connectors 717 on the inside of arms 708 of hingespring elements 712A and 712B effectively creates a preload that allowsthe clip to open wider while still applying the forces needed for thenecrotic process. An alternative, or additional, technique to achievepreloading is to heat hinge spring elements 712A and 712B and shape themduring manufacture.

As best seen in FIGS. 25A and 25B, top and bottom views respectively ofclip 710, hinge spring elements 712A and 712B exert a force oncompressing elements 716A and 716B even when clip 710 is in its closedposition.

Clip 710 is effectively preloaded and a gap 711 (best seen in FIG. 25B)exists between securing elements 714A and 714B even when clip 710 is inits closed position. This gap typically, but without intending to belimiting, is in the range of 0.7 to 0.9 mm, which ensures that the forceexerted by clip 710 falls to zero before it has a chance to cut throughthe healing tissue. It should be remembered that when the necroticprocess is in an advanced stage, tissue thickness is reducedsignificantly.

Gap 711, can be formed in one of many ways. Without intending to belimiting, one of these ways is by forming gap forming projections 713(best seen in FIGS. 25B, 26A and 26B) at the end of one or both ends ofcompressing elements 716A and 716B.

An embodiment of a clip applier 750 that can be used with clip 710 ofFIGS. 25A-26B is shown in FIGS. 27A-28B. While discussed in terms of itsuse with the clip shown in FIGS. 25A-26B, it should readily beunderstood that applier 750, with little or no modification, may be usedwith other clip embodiments discussed above. FIGS. 27A and 27B areisometric views of clip applier 750, the applier shown in its closed andopen position, respectively. FIGS. 27C and 27D are cross-sectional viewsof the applier in FIGS. 27A and 27B, respectively. FIGS. 28A and 28B areisometric views of the clip applier shown in FIGS. 27A-27B in its closedand open position, respectively, when attached to and operating the clipshown in FIGS. 25A-26B.

FIGS. 27A-27D, to which reference is now made, shows a wire or cable 754encased in a sheath 752 which extends toward, and exits from, the bodycavity so that it can be operated by a user. Wire (or cable) 754 isattached to a cam 756 which is positioned inside applier body 760, thelater covered by applier body cover 758. Applier body 760 at its distalend includes a hole 762 on each of two opposing walls. Applier 750includes two arms 764A and 764B each having a projection 768 at theirproximal end and attachment projections 770 at their distal end.Attachment projections 770 attach to clip 710 (FIG. 25A) at itsindentations 718 (FIG. 25A). Arms 764A and 764B each have an aperture(not shown) to receive a pin 766 (FIGS. 27C and 27D) which also passesthrough holes 762 of applier body 760. Pin 766 serves as an axis aroundwhich arms 764A and 764B rotate. Arms 764A and 764B each have a bend 772in them which allows the positioning of projections 768 on arms 774 ofcam 756.

Referring now to FIG. 27C, applier 750 is shown in its closed position.Wire or cable 754 has been pushed in the distal direction, i.e. awayfrom the user, causing attached cam 756 to also move in the distaldirection within applier body 760. Due to the force applied by open clip710 on applier arms 764A and 764B, projections 768 of arms 764A and 764Brotate towards each other around pin 766, towards the center and intothe space 759, best seen in FIG. 27D. Space 759 is formed between camarms 774 and cam flanges 757. This results in applier arms 764A and 764Bmoving to a position where they are adjacent to each other. When applierarms 764A and 764B are brought together, clip 710 is brought to itsclosed position as best seen in FIG. 28A.

Referring now to FIG. 27D, applier 750 is shown in its open position.Wire 754 has been pulled in the proximal direction, i.e. toward theuser, causing attached cam 756 to also move in the proximal direction inapplier body 760. This forces projections 768 of applier arms 764A and764B to rotate in the outward direction. This causes applier arms 764Aand 7648 to move to a position where they are spaced apart from eachother and where projections 768 of applier arms 764A and 764B are pushedand held apart by the wider distal portion of cam arms 774. When arms764A and 764B separate from each other as just described, clip 710 isbrought to its open position as best seen in FIG. 28B.

FIGS. 29 through FIG. 30C, to which reference is now made, show variousviews of another embodiment of a clip applier 800 which may be used withmany of the surgical clips discussed herein. FIG. 29 is an exploded viewof clip applier 800. FIGS. 30A and 30B are isometric views of clipapplier 800 shown in FIG. 29 in its closed and open position,respectively. FIG. 30C is an inner, totally cut-away view of FIG. 30B.

In FIG. 29, there is a wire or cable 812 with a threaded end 814. Wireor cable 812 extends to and exits from the body cavity so that it can beoperated by a user. Threaded end 814 of wire or cable 812 is insertedinto jagged entry 820 of applier body 818. A casing (not shown) of wireor cable 812 is caught on the jagged surface of entry 820. The threadedend 814 of wire or cable 812 is threaded into a threaded bolt 822 ofconfiguration controller 816 when controller 816 is positioned in guideslot 826A (discussed below) of applier body 818. Configurationcontroller 816 is formed to also include two wing elements 824 and aprojection 830.

Applier body 818 includes a first and a second guide slot 826A and 826B,respectively, and configuration controller 816 is positioned so that itrides in first guide slot 826A. Wing elements 824 of configurationcontroller 816 move freely in first guide slot 826A. Proximal ends 828of applier arms 802A and 802B are positioned in and move in second guideslot 826B.

Applier arms 802A and 802B each include an attachment projection 804, ahole 806 and an arm guide slot 808. Projection 804 connects to thesurgical clips in a manner similar to that shown elsewhere herein. Whenthe proximal ends 828 of applier arms 802A and 802B are inserted insecond guide slot 826B, a pin 810 is inserted through hole 829 ofapplier body 818 and through holes 806 in applier arms 802A and 802B.This pin acts as an axis of rotation when arms 802A and 802B are broughtproximate to or spaced apart from each other. When arms 802A and 802Bare inserted into guide slot 826B, projection 830 of configurationcontroller 816 passes through arm guide slots 808 of applier arms 802Aand 802B.

Now referring additionally to FIGS. 30A and 30B, when wire or cable 812is rotated in one direction configuration controller 816 advances in thedistal direction of guide slot 826A with projection 830 (FIG. 29) movingtowards the distal end of arm slots 808 (FIG. 29). This causes applierarms 802A and 802B to rotate towards each other and attain their closedposition. When wire or cable 812 is rotated in the other direction,configuration controller 816 moves in the proximal direction in guideslot 826A and projection 830 moves towards the proximal end of arm slots808 causing applier arms 802A and 802B to rotate away from each otherand attain their open position (FIGS. 30B and 30C). Wing elements 824 ofconfiguration controller 816 prevent turning of controller 816 whenrotated by the threaded end 814 (FIG. 29) of wire/cable 812, therebyallowing for the conversion of rotational motion into translationalmotion.

A fifth embodiment of a surgical compression clip constructed accordingto the present invention is shown in FIGS. 31A-44, to which reference isnow made.

FIG. 31A presents a side cross-sectional view of a surgical compressionclip 70, constructed according to a fifth embodiment of the presentinvention, together with its associated applier 105. FIG. 31B is anenlarged view of the distal end F of a first arm 74 of clip 70,including the clip's latch 80 mechanism.

Clip 70 is formed of a first arm 74 and a second arm 72 which are heldapart from each other by a force exerted by a hinge spring 86 (forceapplier). Hinge spring 86 is made of a shape memory material, typically,but without intending to be limiting, a Ni—Ti alloy. Arms 72 and 74 areformed having teeth 98 on their faces which lie opposite each other. Theteeth are positioned so that they mesh when the arms are broughtproximate to each other. The teeth can be formed as an integral part ofarms 72 and 74. Alternatively, they can be formed as separate elementsand connected to arms 72 and 74 by, for example, welding or by any oneof many other techniques known to those skilled in the art.

Second arm 72 has a slant-shaped guide 85 attached to its distal end F.Guide 85 helps lift latch 80 so that it can snap into place as shown inFIG. 40 to be discussed below. Arms 72 and 74 are typically constructedof metal, e.g. stainless steel or other medical grade metals. However,without being limiting, it may also be constructed of plastic byejection molding. Arms 72 and 74 are formed so that one end of each armreceives the ends of hinge spring 86.

Restrictor element 94 (best seen in FIGS. 37 and 38) extends from theproximal end of arm 72, and is positioned on the proximal side of themost proximal tooth 98. The function of restrictor element 94 is toprevent tissue from entering into the region occupied by hinge spring86. This is essential to ensure that all of the tissue grasped will becompressed; tissue that is not compressed will not undergo the requirednecrotic process.

A latch 80 is inserted in first arm 74 of surgical clip 70. Latch 80 hasa crook-shaped end 84 and includes a straight portion 71. Crook-shapedend 84 is also described herein as an engageable end. This is intendedto indicate that any construction, not necessarily a crook-shapedconstruction, capable of engaging with a catch as described below wouldalso be acceptable. Latch 80 is connected to an anchor element 97 whichlies inside a rectangular hole 75 (best seen in FIG. 35) positioned atthe latch's non-crook shaped end 99. This is best seen in FIG. 31B.Latch 80 is typically formed of a Ni—Ti alloy, but other shape memorymaterials may also be used. Additionally, other materials having someelasticity may also be satisfactory for use.

Shown in FIG. 31A is a wire 90 which runs from the distal end F of arm72 to the distal end F of arm 74. One end 91 of wire 90 is ball-shapedand is attached to latch 80 through first arm 74. The second end of wire90 extends all the way through second arm 72 reaching past proximal endN of clip applier 105, to the proximal, i.e. user, end of an endoscope(not shown). Wire 90 may also be described herein as a cable without anyintent at differentiating between the two descriptions.

Attached to anchor element 97 at the non-crooked shaped end 99 of latch80 is a cable 102 which extends through clip applier 105 past itsproximal end N to the proximal end of the endoscope N (FIG. 1A) where anapplier actuator (e.g. 306 or 308 in FIG. 1A) is located.

Arms 72 and 74 may be considered to consist of both compressing elementsand securing elements and in this way be subsumed into the overallrubric of the other clips discussed herein. In the Figures, each armappears as a single piece but essentially it consists of a bar,typically but without intending to be limiting, with a rounded crosssection having teeth joined to it. The toothed portion (securingelement) may by welded to the round bars (compressing elements) orotherwise joined or produced as an integral part of the round bars. Theround elements are typically hollow and they can be consideredcylindrical. The hollow arms allow insertion therein of hinge spring 86,latch 80, and wires 90 and 102 used to operate clip 70.

FIGS. 32 and 33 are partially exploded views of the elements of surgicalclip 70 and clip applier 105 shown in and discussed in conjunction withFIGS. 31A and 31B. FIGS. 32 and 33 also show applier arms 83 and 89 ofapplier 105 to which first and second arms 72 and 74, respectively, ofclip 70 are joined. Attachment is effected by applier arm projections93; projections 93 extend substantially transversally from the ends ofapplier arms 83 and 89. Applier arm projections 93 are positioned inprojection receptor spacings 95 on arms 72 and 74 when applier 105 isengaged to clip 70.

FIG. 34 shows several isometric and side views of a typical, butnon-limiting, hinge spring 86 design.

FIG. 35 shows the details of latch 80. The straight section 71 of latch80 includes a straight slot 77 with a round hole 79 at its distal end.The end 91 of wire 90 (FIG. 31B) is inserted and held in slot 77, thediameter of end 91 being greater than the width of slot 77. When clip 70is completely positioned around the tissue to be resected, latch 80 issnapped into place, as discussed in greater detail below. As latch 80snaps into place, wire 90 is then detached naturally from latch 80 andfrom clip 70 through hole 79 (FIGS. 35 and 43). After wire 90 is freedfrom latch 80, wire 90 is pulled entirely through second arm 72 towardthe proximal end of the endoscope where it exits the endoscope and thebody. A rectangular hole 75 at the end 99 of straight section 71 oflatch 80 is used to anchor latch 80 to anchor element 97 (FIG. 31B)which is used by the user to pull latch 80.

FIG. 35 also shows that at the end of crook-shaped end 84 of latch 80 isa curved latch snout 92. Curved snout 92 is intended to catch in latchhole 182 discussed below in conjunction with FIGS. 38 and 40. Thisensures that latch 80 snaps into place when clip 70 is in its closedposition, thereby ensuring compression of the tissue between arms 72 and74.

FIG. 36 shows an expanded isometric side view of the hinge spring 86section of clip 70 and the section of clip applier 105 proximate to thissection of clip 70. FIG. 37 shows an isometric front side view of clip70, wire 90 and the distal end of applier 105. Both FIGS. 36 and 37 showclip 70 in its open position.

FIG. 36 shows hinge spring 86 as being inserted into arms 72 and 74 ofclip 70. FIG. 37 shows the attachment of applier arms 83 and 89 whichclose clip arms 72 and 74 by exerting a force counter to the forceexerted by hinge spring 86. The latter tends to force clip 70 open.Applier arms 83 and 89 are attached to arms 72 and 74, respectively, byapplier arm projections 93, the latter being inserted into the clip'sprojection receptor spacings 95. Projections 93 and spacings 95 are alsoshown in FIG. 33. FIG. 36 also shows that applier arms 83 and 89 areintegrally formed with pushing attachments 87 and 81, respectively.These are typically, but not necessarily, single piece elements, that iselements 89 and 81 form a single integral piece and elements 83 and 87form another single integral piece. Alternatively, elements 83 and 87(and 89 and 81) can be welded together from two or more separatestructures.

These pieces include a bend 103 readily recognizable in FIGS. 36 and 38;bend 103 is required to ensure planarity of the pushing device.

Pushing attachments 87 and 81 each has an applier arm slot 88 in which apushing attachment pin 107 moves when rotating pushing attachments 81and 87 around pin 109 (FIGS. 31A and 36).

FIGS. 38-39 show different views of clip 70 and the distal end of clipapplier 105 when wire 90 is pulled taut as a first step in closingapplier 105. The taut wire keeps tissue (not shown) from slipping outwhen positioned between arms 72 and 74 as these arms move toward eachother in a scissor-like or clamp-like fashion.

The wire is pulled taut after the tissue has been brought completelyinto clip 70 in its open position; the tissue is grasped and heldbetween arms 72 and 74 and wire 90. Continuing to pull wire 90 bringsdistal end F (FIG. 31A) of arm 72 close to distal end F (FIG. 31A) ofarm 74 until arm 72 is pressed against the tissue situated between arm72 and arm 74. At this stage, latch 80 is brought to its lockingposition as will be described below. Wire 90 enters arm 72 through wireaperture 104. Wire section 106, best seen in FIG. 41, extends to theproximal end of the endoscope (not shown) and is pulled at that end whenit is desired to bring wire 90 to its taut position between arms 72 and74 of the clip.

FIG. 40 shows the distal end F of clip 70 and the locking action oflatch 80. Between arms 72 and 74, tissue (not shown) is positioned andwire 90 is pulled taut. At that point, the distance between clip arms 72and 74 is small. When arms 72 and 74 are in apposition, latch 80 ispulled by cable 102 (see FIGS. 31A and 37 for example) in a proximaldirection indicated by the wavy double arrows. As latch 80 moves in thedirection of those arrows, the rounded latch head slips (indicated bythe single solid arrow) over slanted guide 85 until it contacts arm 72.It then latches when latch snout 92 (FIGS. 35 and 38) enters latch hole182 (FIGS. 38 and 42). When in that position, latch 80, in concert withhinge spring 86 (force applier), exert a compressive force which acts ina line between arms 72 and 74. In the latched stage, arms 72 and 74 areseparated somewhat, the gap between them arising from the thickness ofthe gripped tissue.

It should readily be understood that any other suitable catch structurecan be used in place of latch hole 182. The choice of a hole here,functioning as a latch catch, should be considered as exemplary only. Aprotrusion with which latch 80 can engage would work equally as well. Infact, any engagement means that can engage and hold latch snout 92 oflatch 80 is contemplated by the present invention.

The tissue situated between arms 72 and 74 of clip 70 prevents the clipfrom fully tracking clip applier 105 and returning to its completelyclosed position. As a result of this lack of complete tracking, applierarm projections 93 disengage from projection receptor spacings 95 bythemselves and applier 105 falls away from clip 70.

As noted above, the shape memory elements used to effect opening orclosing of the compression clips described herein are typicallydescribed as hinge springs. However, these elements can more generallybe classified as and called force appliers. Latch 80, because it istypically formed of shape memory materials, acts as a force applier thatholds compression clip 70 closed.

FIGS. 41-43 show three different views of surgical compression clip 70after latching as described above in conjunction with FIG. 40. FIG. 41best shows exit hole 202 through which cable 102 is attached.Compression clip 70, by anchoring latch 80 to latch hole 182, bringsanchor element 97 to exit hole 202, allowing anchor element 97 tonaturally exit through hole 202. Both cable 102 and anchor element 97are then pulled toward and through applier 105. From there they arepulled toward the proximal end of the endoscope and withdrawn from thebody.

FIG. 44 shows an isometric view of a closed, but unlatched, surgicalcompression clip 70 constructed according to the embodiment shown inFIGS. 31A-43. FIG. 44 reflects the position of clip 70 as it isdelivered to the site of a lesion by applier 105 via a working channelof an endoscope or via a secondary lumen of a multi-lumen sleeveencasing an endoscope. The use of multi-lumen sleeves is discussed belowin conjunction with FIGS. 45-53.

Applier 105 is attached to clip 70 via applier arm projections 93 ofapplier arms 83 and 89 (see for example FIG. 33) at receptor spacings 95on arms 72 and 74. In the closed but unlocked position of FIG. 44, theforce exerted by applier arms 83 and 89 is counter to the force exertedby hinge spring 86. The force provided by applier 105 exerts a forcewhich holds arms 72 and 74 adjacent to each other while clip 70 is beingadvanced within the endoscope (or sleeve lumen) to the lesion. At thesite of the lesion, the force exerted by applier 105 is released and theclip opens.

Tissue is brought between the clip arms, the clip is closed, the lesionis severed and the site of the severed lesion is compressed between arms72 and 74 of the clip 70 until necrosis and healing occurs. The entireprocess is discussed in greater detail below.

It should be noted that wire 90 is pushed forward once clip 70approaches the suspect lesion. This relaxes wire 90 and enables the userto place it over, and/or around, the lesion. The relaxed, extended wirehas a loop with an increased area through which the lesion can bepulled. With clip 70, the open arms 72 and 74 of the clip may be slidfrom the side of the pulled tissue after the polyp is positioned in thearea between arms 72 and 74 and wire 90; this is unlike with clips 10and 710 (FIGS. 2-3B and FIGS. 25A-26B), for example, where the polypmust be pulled through the arms of these latter clips using a grasper(discussed further below). Because of the use of wire 90, larger polypsmay be treated.

A method for effecting full transmural resection using the compressionclips of the present invention is illustrated in FIGS. 45-62 to whichreference is now made.

Operation of the clip in other situations where tissue closure isrequired is similar to its operation as shown in FIGS. 45-62 anddiscussion presented therewith. It should readily be understood by oneskilled in the art, that clip appliers can be designed as the surgicalprocedure and nature of the tissue to be closed warrants. The designwould generally require little or no modification to the applier shownin these Figures, and those shown in concurrently filed pendingapplication “Endoscopic Full Thickness Resection Using SurgicalCompression Clips” owned by the same Applicant, incorporated byreference herein in its entirety.

It should also be readily understood by one skilled in the art thatcertain features of the method and of the working instruments used asshown in FIGS. 45-62 would not be required in other tissue closureprocedures. For example, a severing instrument may not always berequired; similarly, a grasper assembly as used in the Figures may notalways be needed. In some closure procedures commercially availableinstruments may be used.

FIG. 45, to which we now return, shows an endoscope insertion shaft 300with a working channel 154. It also contains several auxiliary elements,here three, denoted as 157A-157C. The number of working and auxiliarychannels may be more or less in other embodiments of shaft 300. Amulti-lumen plastic sleeve 150 is brought to and over endoscopeinsertion shaft 300 (FIG. 46). The endoscope insertion shaft 300 isencased in the primary lumen 155 of the multi-lumen sleeve 150 and theone or more secondary lumens 158 of sleeve 150 are typically collapsedand, if needed, held by bands 160 (FIG. 47A). The bands 160 areexpandable when working instruments are inserted into the collapsedsecondary lumens 158. Insertion of these instruments occurs after thedistal end 152 of the endoscope shaft 300 is positioned proximate to thesuspect lesion. Bands may not be required in some embodiments, if thesecondary lumens 158 remain collapsed by themselves while the encasedendoscope insertion shaft 300 (FIG. 47A) is inserted into a body organor if not required by the physician. It is to be understood that meansor methods other than bands may be used to ensure that the secondarylumens remain collapsed while the encased endoscope shaft is insertedinto the body and positioned near the suspect lesion.

The encased endoscope insertion shaft 300 is advanced within the bodylumen until it is near the lesion, herein taken to be a polyp P in thegastrointestinal (GI) tract. (FIG. 48).

At that point a surgical compression clip 10, and its attached applier30, both in their closed positions, are advanced through a secondarylumen 158 of the sleeve 150 to polyp P. Clip 10 exits the secondarylumen 158 still in its closed position (FIG. 49).

Clip 10, still in its closed position, is brought to its final positionadjacent to polyp P (FIG. 50).

A grasper assembly is then inserted into a working channel 154 of theendoscope insertion shaft 300, advanced through the shaft, and thenadvanced out of the distal end 152 of endoscope insertion shaft 300 tothe region adjacent to polyp P (FIG. 51).

In other embodiments, the grasper assembly, i.e. grasper (not shown) andgrasper transporting element 260, is introduced via a secondary lumen158 of the multi-lumen sleeve 150 and not through a working channel 154of the endoscope shaft. From an operational point of view, this has nosignificant effect on the method described.

In yet another embodiment, the grasper assembly, clip 10 and clipapplier 30 may be advanced through the same secondary lumen 158 from theproximal end of the endoscope shaft to the suspect lesion.

In yet another embodiment, the grasper assembly may be inserted into andadvanced through a second working channel of the endoscopic insertionshaft.

Clip 10 is then opened by applier 30. The opened clip is positioned soas to bound polyp P so that the lesion can be pulled through the clip.FIG. 52 shows an isometric view of this step.

Up to this point, the grasper (not shown) remains inside its graspertransporting element 260. Now the forceps arms 252 of the grasper areejected from grasper transporting element 260 and positioned to grasppolyp P through the open clip (FIGS. 53 and 54).

Polyp P is then pulled by forceps arms 252 into the separatedcompressing and securing elements 16A, 16B and 14A, 14B, respectively,of open clip 10. This is shown in a top side view in FIG. 55. In thisview, one of the forceps arms 252 of the grasper is barely visible; mostof this arm and the entire second forceps arm are obscured by polyp P.

After, or simultaneously with, pulling polyp P, the polyp is rotatedover and wrapped around grasper transporting element 260. This rotationis shown in an isometric view in FIG. 56 and a cross section view (FIG.57) along line AA′ of FIG. 56. Rotation is effected by the rotation ofthe entire grasper assembly, the grasper with forceps arms 252 holdingthe pulled polyp P, the grasper transporting element 260 and theassembly's shaft (not shown) using a control handle positioned outsidethe body cavity. Alternatively, rotating the control handle outside thebody can be avoided by creating a swivel mechanism in the mechanicalconnection with the grasper assembly and rotating the swivel mechanism.Rotation ensures that sufficient tissue is being maneuvered into clip 10and near severing device 310 (shown in FIG. 60) to allow for fulltransmural resection.

Clip applier 30 then closes clip 10 around the pulled and rotated polypP (FIG. 58). Clip applier 30 is detached from the closed clip 10 andwithdrawn via the secondary lumen 158 through which it entered (FIG.59). Alternatively, if the physician feels it will assist him during thetissue resection, clip applier 30 could be detached from clip 10 aftertissue resection.

Polyp P wrapped around grasper transporting element 260 and compressedby clip 10 is severed by a severing device 310 shown being positionedclose to polyp P (FIG. 60). Severing device 310 may be advanced to thepolyp through the endoscope's working channel 154 or through a secondarylumen 158 of sleeve 150. In FIG. 60, severing device 310 has beenadvanced to its position for severing through the secondary lumen 158used for advancing clip 10 and its applier 30. Severing device 310approaches polyp P and severs it from the wall of the GI tract. Theactual step of severing is not shown.

After severance of polyp P, the severed polyp held by the forceps armsof the grasper, together with the remainder of the grasper assembly, thesevering device 310 and the endoscope shaft, are retracted in thedirection of the proximal end of the endoscope and withdrawn from thebody. Withdrawal directly from the body organ is a straight-forwardstep, and therefore this step of the method is not presented in aseparate Figure. Polyp P can then be biopsied or treated as needed by aphysician.

The closed surgical compression clip 10 remains around that portion ofthe GI wall from which the tissue was resected (FIGS. 61, 62A and 62B).Compression continues until necrosis is induced and healing of theresected site occurs. Clip 10 is naturally expelled from the bodythrough the rectum or retrieved by the physician if needed.

The above described method may be operative when employing most of theclips designed according to embodiments of the present invention.

However, clip embodiment five discussed in conjunction with FIGS. 31A-44requires some additional and/or modified steps. The element numberingbelow are those used in conjunction with FIGS. 31A-44 to which referenceshould be made.

The method for using the clip described in conjunction with FIGS. 31A-44includes many of the same steps as those described above. However, thefollowing additional or modified steps emphasize the novel aspects ofthe method associated with clip embodiment five. It does not include allof the steps required, many of which—including the step of rotation—canbe readily understood by reviewing the method described above.

Additional or modified steps when using clip embodiment five include:

Insertion of clip 70 in its closed position together with its applier105;

Releasing the force exerted by applier 105 allowing hinge spring 86 tospread apart arms 72 and 74 of clip 70;

Pushing wire 90 forward and extending it to form a loop;

Placing the wire 90 loop over the polyp;

Pulling the polyp with a grasper through the loop created by theextended wire;

Positioning the arms 72 and 74 of clip 70 in their open position andbringing them around the side of the polyp rather than positioning theclip from the top of the polyp as with other clips discussed in thepresent invention;

Alternatively, the clip may be positioned in proximity to the polyp,after which the polyp is pulled between the open clip arms using agrasper;

Pulling wire 90 taut thereby preventing the polyp from escaping frombetween arms 72 and 74:

Closing arms 72 and 74 by continuing to pull wire 90 and/or usingapplier 105, and pulling cable 102 until latch 80 snaps over the secondclip arm and latches therewith;

Detaching the anchor element 97 which anchors wire 90 to arm 74; andPressing applier 105 slightly to release the applier.

The above step of pulling the polyp with a grasper is optional since inmost situations wire 90 loop by itself can be maneuvered to encompass,grasp and pull the polyp or its stalk.

Positioning the clip from the side as discussed above is a result of thepolyp being encompassed by wire 90 when the latter is in its extendedposition. When made taut, the wire effectively pulls the polyp from alateral position into the waiting open arms 72 and 74 of clip 70.

Generally, insertion of closed clip 70 is effected through a secondarylumen of a multi lumen sleeve, but it also may be advanced through aworking channel of the endoscope. The step of applying applier 105occurs only after clip 70 has exited the secondary lumen or workingchannel.

It is readily understood by one skilled in the art that a full thicknessresection with wide lateral areas (margins) is very difficult to achieveusing conventional surgical approaches and employing conventionalsurgical instruments. This is particularly true of large polyps andespecially large sessile polyps. Grasping and pulling a large section ofa, generally slippery, polyp is very difficult especially given thelimited space available in the body lumen for manipulation of thetissue. In order to overcome this difficulty, the step of rotatingtaught by the method of the present invention is useful. Additionally, aspecially designed grasper assembly as described herein is used toeffect and execute the step of rotating. Both the grasper assembly andstep of rotating may be used to ensure that the entire polyp plus anadequate margin is resected.

In the above discussion of the present invention, the invention has beendescribed as being used in bowel polyp resections. It should be evidentto one skilled in the art that other types of lesions, in other organsin other organ systems, can also be resected using the present inventionwith little or no modification. Such organs include, but are not limitedto, the urinary bladder and other organs of the urinary tract, theuterus, the liver, the esophagus, the gall bladder, the lungs and therectum.

In the above discussion, the system and method of the present inventionhave been described as being used in endoscopic procedures which do notrequire a direct incision into the body cavity. The system and method asdescribed herein above has been described as being inserted into thebody cavity through one of the body's existing orifices. However, it isreadily understood by those skilled in the art that the system andmethod described herein above can be used in open surgical procedureswith little or no modification, where the point of entry of the systemis an incision into the body cavity.

It should be readily apparent to one skilled in the art that the deviceand method of the present invention can be used to excise animal tissueas well as human tissue, particularly, but without being limiting,tissue of other mammalian species.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. In addition, citation or identification of anyreference in this application shall not be construed as an admissionthat such reference is available as prior art to the present invention.

It will be appreciated by persons skilled in the art that the presentinvention is not limited by the drawings and description hereinabovepresented. Rather, the invention is defined solely by the claims thatfollow.

1-31. (canceled)
 32. A surgical clip assembly (70) which comprises: apair of generally linear compression elements (72, 74) for securingtissue therebetween and for applying to the secured tissue a compressionforce, each compression element having a first end portion and a secondend portion, wherein said clip assembly has an initial, open position inwhich said linear compression elements may be positioned about tissue tobe secured therebetween, and a final, closed position whereat saidcompression elements are substantially parallel to each other, therebyto apply a compressive force to the secured tissue; and a first andsecond force means (86, 80) said first force mean being an active hingemember (86) disposed between, and in mechanical communication with, saidfirst end portions of said pair of compression elements (72, 74) andoperative to transmit operational forces therebetween, wherein when saidclip assembly (70) is in its open position, said linear compressionelements (72, 74) form a jaw-like arrangement with said second endportions of said linear compression elements (72, 74) spaced apart so asto permit positioning of said compression elements (72, 74) about tissueto be secured therebetween.
 33. A surgical clip assembly (70) accordingto claim 32 wherein said second force means (80) is a selectably movablelatch member (80) positioned within a first of said two compressionelements (74) selectably movable to engage an engagement means (182) onsaid second compression element (72).
 34. A surgical clip assembly (70)according to claim 33, wherein said selectably movable latch member (80)positioned within a first of said two compression elements (74) extendspast its second end portion, said engagement means (182) positioned onsaid second end portion of said second compression element (72) engagesand holds said latch member (80) in force producing engagement when saidpair of compression elements (72, 74) are brought close to each other.35. A surgical clip assembly (70) according to claim 33, furtherincluding a wire (90) extending between said second end portion of eachof said two compression elements (72, 74), said wire (90) releasablyconnected to said latch member (80) said wire operative to preventtissue to be compressed from moving out from between said pair ofcompression elements (72, 74) while said assembly (70) is brought to itsclosed position.
 36. A surgical clip assembly (70) according to claim 35wherein said wire having an extension extending via said second endportion of said second compression element (72) through said firstcompression element (74), said extension operative to draw said wire(90) taut when tissue is positioned between said two compressionelements, said taut wire (90) thereby preventing the tissue from movingout from between said pair of compression elements (72, 74) while saidclip assembly (70) is brought to its closed position.
 37. A surgicalclip assembly (70) according to claim 32, wherein at least one of saidtwo force means (86, 80) is formed of a shape memory material.
 38. Asurgical clip assembly according to claim 32, wherein said active hingemember (86) is fixably connected to said first end portions of saidlinear compression elements.
 39. A surgical clip assembly (70) accordingto claim 32, said clip assembly (70) for use with a clip applier (105)having an attachment element (93), said clip assembly (70) furthercomprising at least one receiving structure (95) sized and configured todisengageably receive the attachment element (93) of the clip applier(105), the clip applier exerting a force counter to the force exerted bysaid active hinge member (86) and operable for bringing the clipassembly from its closed position to its open position or vice versa.40. A surgical clip assembly (70) according to claim 32, wherein saidtwo force means (86, 80) are non-unitary with said pair of linearcompression elements (86, 80).
 41. A surgical clip assembly (70)according to claim 32 further including a restrictor element (94)extending from said first end portion of one of said compressionelements thereby preventing tissue from entering the region occupied bysaid active hinge member.